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Annora’s notice letter does not provide a Paragraph IV certification against our other patents listed in the Orange Book.
−Removed: On July 25, 2022, we filed a lawsuit in the US District Court for the District of New Jersey against Annora and its subsidiaries Hetero Labs Ltd., and Hetero USA, Inc., for infringement of our US patents identified in Annora’s
−Removed: Paragraph IV certification.
−Removed: These patents are listed in the FDA’s Orange Book and cover TAVALISSE.
+Added: On July 25, 2022, we filed a lawsuit in the US District Court for the District of New Jersey against Annora and its affiliates, Hetero Labs Ltd., and Hetero USA, Inc., for infringement of our US patents identified in Annora’s Paragraph IV certification.
+Added: On September 21, 2022, Annora and its affiliates answered and counterclaimed for declaratory judgment of non-infringement and invalidity of the ’458, ’122, ’492, ’648, and ’504 patents.
+Added: We filed an answer to Annora’s counterclaims on October 12, 2022.
We intend to vigorously enforce and defend our intellectual property related to TAVALISSE.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.